Pharmacokinetics of Oral Zoliflodacin 3 g in Healthy Lactating Women

ClinicalTrials.gov ID: NCT07926997

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Official title

An Open-label Study to Evaluate the Pharmacokinetics of a Single Oral Dose of Zoliflodacin 3 g in Milk and Plasma in Healthy Lactating Women

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a single-arm clinical trial to evaluate the PK profile in breast milk and plasma after a single oral dose of zoliflodacin in healthy lactating women. Eligible participants who have been actively breastfeeding or expressing milk for at least 4 weeks postpartum will receive a single dose of zoliflodacin administered as an oral suspension with food. Breast milk and plasma samples will be collected at predefined time points for up to 48 hours after dosing to characterize zoliflodacin concentrations and estimate drug exposure in breast milk and maternal plasma. Participants will temporarily discontinue breastfeeding from study check-in until 72 hours after dosing to avoid infant exposure to zoliflodacin. Breast milk will be expressed using an electronic breast pump and collected according to the study schedule. Participants will be admitted to the clinical research unit the day before dosing and discharged after completion of the 48-hour PK sampling period. A follow-up visit will be conducted approximately 7 days after dosing to assess safety and tolerability. A lactation consultant will be available throughout the study period and for up to 30 days after dosing, as needed.

Study identification

NCT ID: NCT07926997
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Phase 4
Lead sponsor: Global Antibiotics Research and Development Partnership; Other
Enrollment: 10 participants

Conditions and interventions

Conditions

Lactation

Interventions

Zoliflodacin Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: Female
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 2026 (Estimated)
Primary completion: Jun 2027 (Estimated)
Completion: Aug 2027 (Estimated)
Last update posted: Nov 9, 2026

2026 – 2027

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
TrialMed	Las Vegas	Nevada	89113	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07926997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 9, 2026 · Synced Nov 15, 2026